Pharmaceutical >> Microbiology >> Sterile and Non-Sterile Product Testing

Sterile and Non-Sterile Product Testing

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Eurofins BioPharma Product Testing offers a comprehensive range of microbiology services with strict adherence to cGMP requirements in support of sterile and non-sterile product testing and facility monitoring for bio/pharmaceuticals, including raw materials, cell lines and unprocessed bulk testing.

Why Choose Eurofins BioPharma Product Testing?

  • We have been a pioneer in the microbiology outsourcing  industry for over 25 years, offering experience that includes more than 3,000 product validations.
  • We have one of the largest networks of GMP Microbiology  laboratories in the industry, including 14  laboratories in Europe and the US assuring that you  will have the resources necessary to complete your  project quickly and effectively.
  • We routinely and deliberately drive collaboration on  services, regulations and new technology across our  network so that we operate with a consistent level of  scientific expertise and offer a consistent, marketleading  product to our customers
  • We perform every year more than 10.000 sterility  tests, more than 22.000 organism identifications,  more than 2.200 preservative efficacy tests and overall  we process more than 230.000 routine samples  including product, water and environmental samples
  • Our state-of-the-art controlled and HEPA-filtered  microbiology laboratory facilities ensure contamination-free testing of your products.
  • Our harmonized methods support multiple compendia  including USP, EP, JP, PTC and 21 CFR.

Testing Available

  • Mycoplasma
  • Sterility
  • Endotoxin
  • Particulate Matter
  • Microbial Immersion Studies
  • Sterilization Validation
  • Media Fills
  • Microbial Limits
  • Antimicrobial Preservative Effectiveness
  • Antibiotics potency assays
  • MIC/MBC Studies
  • Bioburden Studies
  • Water Activity
  • Process Water Testing
  • Environmental Monitoring
  • Disinfectant Efficacy Testing
  • Biological Indicator Analysis
  • Organism Identification

 Instrumentation

  • MicroSeq® Microbial Identification Systems
  • Isolator systems
  • BactAlert 3D
  • Endoscan V and Kinetic QCL systems for Kinetic Turbidimetric/ Chromogenic Endotoxin Testing
  • More than 13 Sievers TOC analyzers
  • More than 75 Biosafety cabinets - capable of handling Biosafety Level 2 materials